Apex Tubing Set

• • Terminated Z-1680-2013 FDA Class II ·initiated 30 May 2013

  Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.

510(k) Number

K954440 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K013369 Active Cleared 4 Apr 2002

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